21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud

21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud
by David Nettleton

Mumbai, India
30th & 31st October, 2018
Time: 9 AM to 6 PM

Venue: The Leela Mumbai
Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059

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Overview:

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.
Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.
Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Course Objectives:

Understand what is expected in Part 11 and Annex 11 inspections
Avoid 483 and Warning Letters
Learn how to buy COTS software and qualify vendors.
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Requirements for local, SaaS, and cloud hosting
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
Minimize the validation documentation to reduce costs without increasing regulatory or business risk
Write test cases that trace to elements of risk management
Protect intellectual property and keep electronic records safe

Who will benefit:

QA, IT, management
all GxP system users

Agenda:

Day One

Lecture 1:

Introduction to the FDA

How the regulations help your company to be successful
Which data and systems are subject to Part 11

Lecture 2:

21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures

What Part 11 means to you, not just what it says in the regulations
Avoid 483 and Warning Letters
Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
How SaaS/cloud computing changes qualification and validation
Ensure data integrity, security, and protect intellectual property
Understand the current computer system industry standards for security, data transfer, and audit trails
Electronic signatures, digital pens, and biometric signatures
SOPs required for the IT infrastructure
Product features to look for when purchasing COTS software
Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Lecture 3:

The Five Keys to COTS Computer System Validation

The Who, What, Where, When, and Why of CSV

Day Two

Lecture 1:

Ten-Step Process for COTS Risk-Based Computer System Validation

Learn which documents the FDA expects to audit.
How to use the risk-based validation approach to lower costs.
How to link requirements, specifications, risk management, and testing.
Document a computer system validation project using easy to understand fill-in-the-blank templates.
Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Lecture 2:

How to Write Requirements and Specifications

Workshop for writing requirements and then expanding them for specifications

Lecture 3:

How to Conduct a Hazard Analysis/Risk Assessment-Exercise

Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

Lecture 4:

Software Testing

Reduce testing by writing test cases that trace to elements of risk management.
How to write efficient test cases

Lecture 5:

System Change Control

How to manage a validated system with minimal documentation

Lecture 6:

Purchasing COTS Software

How to purchase COTS software and evaluate software vendors.

Lecture 7:

Cost Reduction Without Increasing Regulatory or Business Risk

How to save money
How to increase quality
How to increase compliance with less documentation

Price
₹ 16,000
* + 18% GST
Click here to download Registration form
Payment Options

You can register for this seminar paying either by cheque or Demand Draft. To register, please make out your cheque or Demand Draft for the prescribed amount and send it to the address given below:
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA

Group participations
Discount Slab: 5 or more participants 10% discount
To avail the above group discounts, all the participants should register by making a single payment.
Call our representative TODAY on 7676504662 to have your seats confirmed!
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Bank Name: ICICI Bank
Account Name: NetZealous Services India Private Limited
Account Type: Current Account
Account Number: 100705001045
IFSC Code: ICIC0001007
MICR Code: 560229039
Branch Address: ICICI Bank, Bannerghatta Road, Bangalore - 560076

Venue:

The Leela Mumbai Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059

Speaker:

David Nettleton

Director & FDA Compliance Specialist,
Computer System Validation and FDA Compliance consultant

Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

Managing the Documentation Maze - Answers to Questions You Didn't Even Know to Ask (Wiley - www.wiley.com) 2010
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com, 2004)
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org, 2003).

Mumbai Local Attractions

Mani Bhavan Gandhi Museum

Mahatma Gandhi once lived in this simple, two-story building, which is now a museum, library and research center depicting Gandhi's life and struggles for Indian freedom through peaceful means.

Bandra-Worli Sea Link

This is a bridge which links Mumbai's suburbs to South Mumbai. It's a very prestigious bridge which was opened in 2009.

Marine Drive

Landmarks/ Points of Interest; Scenic Drives Bordering the Arabian Sea, this famous road is a popular spot for watching sunsets, and is gorgeous when lit up at night.

Gateway of India

The Gateway of India is of course, the logical place from where to begin your tour of Mumbai. After all, you're following in the footsteps of royalty! The English King George V landed in India in 1911 at this very spot, and the citizens of Bombay pooled money and ideas to build this grand memorial to him.

Chowpatty Beach

The action starts at night at this famous beach, which is lined with vendors, entertainers, children's rides and fast food stalls selling bhelpuris (puffed rice snacks) and other Indian delights.

Chhatrapati Shivaji Terminus

India's most beautiful railway station is a masterpiece of Gothic architecture with stained-glass windows, towering spires, domed arches and buttresses and pillars with animal images carved into them.